Tempe, Arizona 85283

  • Obesity

Purpose:

This trial is conducted in the United States of America. The aim of the trial is to investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) for single doses and multiple doses of NNC0165-1562 in overweight to obese but otherwise healthy subjects.


Criteria:

Inclusion Criteria: - Part I (SD): - Male, aged 18-55 years (both inclusive) at the time of signing informed consent - Body mass index (BMI) between 25.0 and 34.9 kg/m^2 (both inclusive). Overweight should be due to excess of adipose tissue, as judged by the investigator - Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator - Part II (MD): - Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent - Body mass index (BMI) between 27.0 and 39.9 kg/m^2 (both inclusive). Overweight should be due to excess of adipose tissue, as judged by the investigator - Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator Exclusion Criteria: - Any clinically significant weight change (at least 5% self-reported change during the previous 3 months), dieting attempts (e.g. participation in an organised weight reduction programme within the last 3 months), prior obesity surgery, or medications affecting body weight within 3 months prior to screening - Male subjects who are not surgically sterilised (vasectomy) and are sexually active with female partner(s) who are not using a highly effective method of contraception (such as condom with spermicide) combined with a highly effective method of contraception for their non-pregnant female partner(s) (Pearl Index 1%, such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical cap+spermicide), and/or intend to donate sperm in the period from screening until 3 months following administration of the investigational medical product - Female subjects who are of child bearing potential (pre-menopausal and not surgically sterilised) and are sexually active with male partner(s) who are not surgically sterilised (vasectomy) and are not using highly effective contraceptive methods (Pearl Index 1%,such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical cap+spermicide) combined with a highly effective method of contraception for their male partner(s) (e.g. condom with spermicide), and/or are pregnant, breast-feeding or intend to become pregnant) (applicable to Part II (MD) only)


Study is Available At:


Original ID:

NN9747-4194


NCT ID:

NCT02568306


Secondary ID:

U1111-1164-6546


Study Acronym:


Brief Title:

A First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses and Multiple Doses of NNC0165-1562 in Overweight to


Official Title:

A First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses and Multiple Doses of NNC0165-1562 in Overweight to Obese But Otherwise Healthy Subjects.


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

55 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Novo Nordisk A/S


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

93


Enrollment Type:

Actual


Overall Contact Information

Official Name:Global Clinical Registry (GCR, 1452)
Study Director
Novo Nordisk A/S

Study Dates

Start Date:October 5, 2015
Completion Date:February 7, 2017
Completion Type:Actual
Primary Completion Date:February 7, 2017
Primary Completion Type:Actual
Verification Date:July 2018
Last Changed Date:July 12, 2018
First Received Date:October 2, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:The time to maximum plasma concentration of NNC0165-1562 at steady state, Part II (MD)
Time Frame:From baseline (Day 1) until the follow-up visit (Day 85)
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:The maximum plasma concentration of NNC0165-1562 at steady state, Part II (MD)
Time Frame:From baseline (Day 1) until the follow-up visit (Day 85)
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:The area under the NNC0165-1562 plasma concentration-time curve, Part II (MD)
Time Frame:From time 0 to 24 hours at steady state. From baseline (Day 1) until the follow-up visit (Day 85)
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:The time to maximum plasma concentration of NNC0165-1562 after a single s.c.dose, Part I (SD)
Time Frame:From baseline (Day 1) until the follow-up visit (Day 29)
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:The maximum plasma concentration of NNC0165-1562 after a single s.c. dose, Part I (SD)
Time Frame:From baseline (Day 1) until the follow-up visit (Day 29)
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:The area under the NNC0165-1562 plasma concentration-time curve, Part I (SD)
Time Frame:From time 0 to 24 hours after a single s.c. dose. From baseline (Day 1) until the follow-up visit (D
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Number of TEAEs, Part II (MD)
Time Frame:From time of dosing (Day 1) until completion of the follow-up visit (Day 85)
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Number of treatment emergent adverse events (TEAEs), Part I (SD)
Time Frame:From time of dosing (Day1) until completion of the follow-up visit (Day 29)
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:NNC0165-1562
Description:Administered subcutaneously (s.c., under the skin) single dose [SD] or multiple dose [MD] with daily dosing.
Arm Name:NNC0165-1562
Intervention Type:Drug
Name:placebo
Description:Administered subcutaneously (s.c., under the skin) single dose [SD]) or multiple dose [MD] with daily dosing.
Arm Name:Placebo

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Placebo
Study Arm Type:Experimental
Arm Name:NNC0165-1562

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Novo Nordisk A/S

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: March 26, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.